DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 6 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 6, the limitation “a biasing member” is indefinite because it is unclear if this biasing member is the same as the “biasing member” introduced in preceding claim 2. For examination purposes, the “biasing member” introduced in claim 6 will be interpreted as a second biasing member.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 24-28, 32-35, and 38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kohlbrenner et al (US 2014/0350484).
Regarding claim 1, Kohlbrenner discloses:
An injection device (Fig. 1A) for injecting medicament in a patient (¶0003) comprising: a housing (20) configured to house a fluid reservoir (40) having one of a plurality of volumes of medicament (¶0071 – multiple dose settings can be made, meaning there are multiple doses available); an injection conduit (32; Fig. 2) fluidly coupled to the fluid reservoir (40) configured to define a fluid pathway from the fluid reservoir (40) to the patient (¶0068); a firing mechanism (90; ¶0071) coupled to the fluid reservoir (40) and configured to expel the medicament from the fluid reservoir (40) through the injection conduit (32); a volume setting mechanism (220) coupled to the firing mechanism (90) and configured to be adjusted to select the one of the plurality of volumes of medicament for the firing mechanism (90) to expel (¶0072, 0090-0091 – dose limiting arrangement limits the maximum remaining available residual dose); and a dose setting mechanism (60) configured to be adjusted to select a fraction of the one of the plurality of volumes of medicament that is injected from the injection conduit (32) when the firing mechanism (90) is actuated (¶0069, 0071).
Regarding claim 24, Kohlbrenner discloses:
The injection device of claim 1, wherein the firing mechanism (90) includes a spring (190) and the position of the spring (190) being independent from the position of the dose setting mechanism (60).
Regarding claim 25, Kohlbrenner discloses:
The injection device of claim 1, wherein the dose setting mechanism (60) includes a knob rotatably coupled to the housing (20) (¶0069 – the dose setting mechanism is in the form of a knob, see Fig. 1A).
Regarding claim 26, Kohlbrenner discloses:
The injection device of claim 1 further comprising a guard (10) slideably coupled to the housing (20) and configured to extend axially past the injection conduit (32) and lock relative to the housing (20) after removing the injection conduit (32) from the patient (¶0068 – sleeve 10 slides over carpule sleeve 30 to protect from needle 32).
Regarding claim 27, Kohlbrenner discloses:
The injection device of claim 1, wherein the injection conduit (32) comprises a needle (¶0068).
Regarding claim 28, Kohlbrenner discloses:
The injection device of claim 27 further comprising a syringe (30) containing the fluid reservoir (40), wherein the needle (32) is fixed to the syringe (30).
Regarding claim 32, Kohlbrenner discloses the injection device of claim 1, wherein the firing mechanism (90) is fully capable of delivering each of the selected fraction of the one of the plurality of volumes of medicament over a generally equal amount of time as compared to one another, for example if each fraction is the same size each injection time would be the same.
Regarding claim 33, Kohlbrenner discloses the injection device of claim 1, wherein the fraction is fully capable of being only greater than or equal to 0.5, for example if the dose is set to be half of the total volume of the reservoir (40).
Regarding claim 34, Kohlbrenner discloses the injection device of claim 1, wherein the selected fraction is fully capable of resulting in a residual volume remaining in the fluid reservoir after delivery of 0.18 ml or less, for example if the selected fraction is 0.82 ml of the 1 ml reservoir (40).
Regarding claim 35, Kohlbrenner discloses:
An injection device (Fig. 1A) for injecting medicament in a patient (¶0003) comprising: a firing mechanism (90) having an actuator (80) and configured to be selectively preset during assembly to one of a plurality of positions based on a maximum volume of medicament to be delivered to the patient (¶0071); and a dose setting mechanism (60) configured to be selectably adjusted upon use, independent of the preset of the firing mechanism (90), to select a fraction of the maximum volume of medicament to be delivered to the patient (¶0069).
Regarding claim 38, Kohlbrenner discloses:
A method for assembling an injection device (Fig. 1A) comprising: inserting a fluid container (40) having a fluid reservoir (R) including one of a plurality of volumes of medicament (¶0071) into a housing (20), the fluid container (40) including an injection conduit (32) fluidly coupled to the fluid reservoir (R) configured to define a fluid pathway from the fluid reservoir (R) to the patient (¶0071); setting a volume setting mechanism (220) based on a size of the one of the plurality of volumes of medicament (¶0072, 0090-0091 – dose limiting arrangement limits the maximum remaining available residual dose); coupling the volume setting mechanism (220) to a firing mechanism (90); and coupling the firing mechanism (90) to the fluid reservoir (R), the firing mechanism (90) configured to expel the medicament from the fluid reservoir (R) through the injection conduit (32), the firing mechanism (90) being coupled to a dose setting mechanism (60) configured to select all or a fraction of the one of the plurality of volumes of medicament that is injected from the injection conduit (32) when the firing mechanism (90) is actuated (¶0069, 0071).
Claims 1, 13, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bartha (US 2011/0034881).
Regarding claim 1, Bartha discloses:
An injection device (Fig. 1) for injecting medicament in a patient (¶0018) comprising: a housing (34; Fig. 2) configured to house a fluid reservoir (12) having one of a plurality of volumes of medicament (¶0018); an injection conduit (¶0018 - needle) fluidly coupled to the fluid reservoir (12) configured to define a fluid pathway from the fluid reservoir (12) to the patient (¶0018); a firing mechanism (14) coupled to the fluid reservoir (12) and configured to expel the medicament from the fluid reservoir (12) through the injection conduit (¶0018); a volume setting mechanism (52) coupled to the firing mechanism (14) and configured to be adjusted to select the one of the plurality of volumes of medicament for the firing mechanism (14) to expel (¶0018); and a dose setting mechanism (50) configured to be adjusted to select a fraction of the one of the plurality of volumes of medicament that is injected from the injection conduit when the firing mechanism (14) is actuated (¶0022).
Regarding claim 13, Bartha discloses:
The injection device of claim 1, wherein the volume setting mechanism (52) includes a retainer (28) and a latch (38) and the firing mechanism (14) includes a ram (14) and a biasing member (46; Fig. 3) (¶0018), the latch (38) being coupled between the biasing member (46) and the ram (14), the latch (38) being retained against a force of the biasing member (46) in an initial position by the retainer (28) (¶0027).
Regarding claim 19, Bartha discloses:
The injection device of claim 13, wherein the latch (38) includes a plurality of axially spaced indentations each configured to engage with a projection of the retainer (28) (¶0027).
Claim 39 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lawlis et al (US 2013/0324965).
Regarding claim 39, Lawlis discloses:
An injection device (Fig. 1A) for injecting medicament in a patient (¶0004) comprising: a housing (110) configured to house a fluid reservoir (130); an injection conduit (910; Fig. 9A) fluidly coupled to the fluid reservoir (130) configured to define a fluid pathway from the fluid reservoir (130) to the patient (¶0117); a firing mechanism (116; Fig. 1B) coupled to the fluid reservoir (130) and configured to expel the medicament from the fluid reservoir (130) through the injection conduit (910) (¶0086); and a safety cap (120) coupled to a distal end of the housing (110), the safety cap (120) being coupled to the firing mechanism (116) such that decoupling the safety cap (120) from the housing (110) allows the firing mechanism (116) to advance a predetermined distance relative to the fluid reservoir (130) to prime the fluid reservoir (130) (¶0091).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Kohlbrenner in view of Lawlis.
Regarding claim 29, Kohlbrenner discloses the injection device of claim 1 but is silent regarding “wherein the injection device is configured to prevent resetting after the firing mechanism is actuated so as to prevent a subsequent injection of the medicament by the injection device, thereby configuring the injection device as a single-use injector.” However, Lawlis teaches an injection device (Fig. 1A), thus being in the same field of endeavor, comprising a reuse prevention feature in the form of a spring-loaded needle shield (1025) that extends and shield the needle of the device after use (¶0126). The shield locks into the extended position after use to prevent reuse of the device (¶0126). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the device of Kohlbrenner to incorporate a feature to prevent resetting after the firing mechanism is actuated as taught by Lawlis in order to prevent sufficient structure to prevent subsequent injections of the device and form a single-use injector.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 2-5, 7-12, 31, and 36-37 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-4, 6-11, 22, and 37-38 of prior U.S. Patent No. 10,661,014. This is a statutory double patenting rejection.
Instant
2
3
4
5
7
8
9
10
11
12
31
36
37
Patent
1
2
3
4
6
7
8
9
10
11
22
37
38
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 6, 24-30, 32-35, and 38-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 12-21, 36, and 39 of U.S. Patent No. 10,661,014. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims anticipate each and every limitation of the instant claims as detailed below:
Instant
1
6
24
25
26
27
28
29
30
32
33
34
35
38
39
Patent
1
5
12
13
14
15
16
17
18
19
20
21
36
39
18
Allowable Subject Matter
Claims 14-18 and 20-23 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TASNIM M AHMED whose telephone number is (571)272-9536. The examiner can normally be reached M-F 9am-5pm Pacific time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at (571)272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TASNIM MEHJABIN AHMED/Primary Examiner, Art Unit 3783